FDA Commissioner: Device Approvals Process Set to Become Less Burdensome

The head of the FDA, Commissioner Margaret Hamburg, ”sounds an optimistic tone” claiming approval process for medical devices is about to become considerably smoother thanks to the passage of the Medical Device User Fee Amendments (MDUFA), reports the Minneapolis Star Tribune.

Hamburg was attending a meeting with Sens. Al Franken (D-MN) and Amy Klobuchar (D-MN) and representatives from the medical device industry in Minnesota regarding the pace at which FDA regulators are approving medical devices. The agency has come under frequent criticism from the industry for what companies see as an unnecessarily slow approval process compared to that of the EU. This despite a recent study published in the New England Journal of Medicine (NEJM) shows that US medical device approvals are actually faster than the approvals process in the EU when reimbursement decisions are also taken into account.

“One reason I think it’s going to change is we’re starting to see change already,” Hamburg said, adding that passage of the legislation — which includes a new fee agreement between the medical technology industry and the FDA — will give the agency additional resources and authority.

For instance, an additional 200 people will review and approve medical devices, she told the Tribune. There also will be more resources for training reviewers and stronger management of the review process. The new legislation also gives the FDA greater flexibility, such as a loosening of the conflict-of-interest rules that will allow a greater number of outside scientists to review proposed medical devices.